Kornimate/medical-research-clean huggingface dataset:
stroke process in femoral versus radial access

Conditions: Ischemic Stroke, Acute

Summary: in patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.

investigators will compare the procedure times, angiographic results as well as the clinical evolution and the patient's experience during their hospital stay and after discharge, depending on the arterial access practiced for mechanical thrombectomy.

Eligibility criteria:
inclusion criteria: * patients with high suspicion of ischemic stroke due to large cerebral vessel occlusion defined by nihss\> 10. * immediate availability of the entire team responsible for endovascular treatment (neurologist, neurointerventional physician, anesthetist, nursing, technicians ...) * radial artery diameter ≥2.5 mm * presence of femoral pulse or patency by ultrasonography in its defect. * previous functional independence (mrs 0-2). exclusion criteria: * life expectancy of less than 6 months. * intracranial hemorrhage * patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations. * no availability for follow-up after 90 days.

Keywords: radial access femoral access thrombectomy
a study of lumacaftor in combination with ivacaftor in cystic fibrosis subjects aged 12 years and older who are homozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Summary: the primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at week 24 in participants aged 12 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation on the cf transmembrane conductance regulator (cftr) gene.

this was a phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter study of orally administered lumacaftor in combination with ivacaftor in participants aged 12 years and older with cf who are homozygous for the f508del-cftr mutation. the study included a screening period (day -28 through day -1), a treatment period (day 1 \[first dose of study drug\] to week 24 ± 5 days), and a safety follow-up visit (4 weeks ± 7 days after the week 24 visit).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * homozygous for the f508del cftr mutation * forced expiratory volume in 1 second (fev1) greater than or equal to (\>=) 40 percent (%) and less than or equal to (=\<) 90% of predicted normal for age, sex, and height * willing to remain on a stable cf medication regimen through week 24 or, if applicable, the safety follow up visit exclusion criteria: * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug * history of solid organ or hematological transplantation * history of alcohol or drug abuse in the past year * ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening. * use of strong inhibitors, moderate inducers, or strong inducers of cytochrome p450 3a (cyp3a) within 14 days before day 1 of dosing
in vivo evaluation of the physiological effects of arabinoxylan-oligosaccharides (axos) in healthy subjects (juniors)

Conditions: Gastrointestinal Health; Healthy Subjects

Summary: the investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (axos) preparation extracted from wheat bran (hereafter called wheat bran extract, wbe). the objective of this study is to analyze the effect of the intake of wbe on various parameters of gastrointestinal health in children (8-12 yrs). additionally, safety was analyzed using treatment emergent adverse events (aes).


Eligibility criteria:
inclusion criteria: * regular eating habits * consent to take in the study product according to the study protocol * consent of parents for follow-up of the protocol * subject is willing to maintain his/her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol) exclusion criteria: * low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial * recent use of antibiotics * abdominal surgery in the past * use of medication or dietary supplements known to influence gastrointestinal tract within two weeks of start of clinical trial. examples of such medication/dietary supplements are antispasmodics, anti-diarrhea medication and/or probiotic medication * serious illness within 3 months of start of clinical trial * chronic gastrointestinal conditions such as inflammatory bowel disease (ibd), irritable bowel syndrome (ibs), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance * complete anesthetics within 3 month of the start of the clinical trial * allergy for wheat products * celiac disease * subject has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk
telephone call from acute care physicians to long term care physicians: impact on transitional care of elderly patients

Conditions: Alzheimer Disease; Parkinson Disease; Dysphagia

Summary: a telephone call from a physician taking care of a patient in the hospital to a physician in the long term care setting at the time of discharge can improve transitional care for elderly patients. we believe direct communication between physicians can reduce re-hospitalizations, medication errors, morbidity and mortality. no studies have been done that involve physician-to-physician sign-outs after hospital discharge to the nursing home. in our study, we would like to address the breakdown in the transfer of information to the nursing home setting.


Eligibility criteria:
inclusion criteria: * patients transitioning from the acute care for the elderly (ace) unit patients at maimonides medical center to metropolitan jewish geriatric center (mjgc). exclusion criteria: * age below 65

Keywords: alzheimer's d-se parkinson's d-se frailty
the effect of low intensity shockwave therapy for ed in post radical prostatectomy patients who didn't respond to pde5i

Conditions: Erectile Dysfunction

Summary: low intensity shock wave therapy (li-eswt) was shown to have a beneficial effect on ed patients responding to pde5i's. this study aimed to determine the capability of li-eswt to affect patients who underwent radical prostatectomy who did not respond to pde5 inhibitor therapy.

we included severe ed patients that underwent radical prostatectomy at least one year previously and failed to respond to pde5i therapy, who scored 0-2 on the rigidity scale (rs) during pde5i therapy. treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. at each session li-eswt was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). one-month after end of treatment the same baseline assessment was repeated. an active pde5i medication regime was then provided and final erectile function was reassessed. main endpoints for success were changes in rs and in the international index of erectile function (iief-ed) domain score. this study further emphasises the need to study specific populations with unique etiologies causing ed.

Eligibility criteria:
inclusion criteria: * post radical prostatectomy * ed of more than 6 months * rigidity score ≤ 2 during pde5i therapy * stable heterosexual relationship for more than 3 months * patients need to know and to agree that the study protocol does not allow any pde5i therapy till week 13 . exclusion criteria: * prior surgery or radiotherapy in pelvic region * any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities * clinically significant chronic hematological disease * anti-androgens, oral or injectable androgens * cardiovascular conditions that prevent sexual activity

Keywords: li-eswt erectile dysfunction radical prostatectomy non pde5 inhibitor responders shock wave
multilevel hpv self-testing intervention for the increase of cervical cancer screening among women in appalachia

Conditions: Cervical Carcinoma; Human Papillomavirus Infection

Summary: this trial studies how well a multilevel human papillomavirus (hpv) self-testing intervention works in increasing cervical cancer screening among women in appalachia. most cases of cervical cancer occur among unscreened and underscreened women. a multilevel hpv self-testing intervention may help to improve cervical cancer screening rates.

primary objectives: determine the effectiveness of the intervention in increasing cervical cancer screening. outline: participants are randomized to 1 of 2 groups. group i: participants receive the hpv self-testing intervention consisting of mailed hpv self-test devices. participants also receive an information about cervical cancer. participants who do not return their self-test within a few weeks receive telephone-based patient navigation. group ii: participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.

Eligibility criteria:
inclusion criteria: * not within recommended cervical cancer screening guidelines for women in this age range (i.e., no papanicolaou \[pap\] test in last 3 years or no pap test plus clinic-based hpv test in last 5 years) * resident of an appalachian county * not currently pregnant * intact cervix * no history of invasive cervical cancer * seen in a participating clinic/health system in last 2 years (i.e., active patient) * have a working telephone
comparison of two different insulin dose calculation algorithms in type 1 diabetes

Conditions: Insulin-Dependent Diabetes Mellitus 1

Summary: the aim of this study is to compare the impact of carbohydrate counting (cc) method which is standard insulin dose calculation algorithm and food insulin index (fii) method which is a new algorithm on postprandial glucose following a high fat and a high protein meal in adolescent with type 1 diabetes. a randomized, single-blind and crossover trial included 14 adolescents aged 14-18 years with type 1 diabetes. all participants were sent to their homes for 4 consecutive days with a different glycemic index breakfast. the insulin doses of the meals were calculated according to cc and fii methods. test breakfasts with different gis and insulin requirements calculated with different algorithms are as follows: high gi calculated by cc (chgi), low gi calculated by cc (clgi), high gi calculated by fii (fhgi) and low gi calculated by fii (flgi).


Eligibility criteria:
inclusion criteria: * aged between 14-18 years adolescents * type 1 diabetes diagnosed for at least one year * performing self-monitoring of blood glucose and doses of insulin at least four times daily * hba1c ≤ 9.6% for the last three months * negative fasting c-peptide (\<0.1 nmol/l) * total daily insulin use of ≥ 0.5 u/kg * world health organization bmi/age z-score of -1 to below 3 exclusion criteria: * complications of diabetes or other medical conditions including celiac disease * treatment with oral hypoglycaemic agents * food allergies, intolerances, or eating disorder * intestinal malabsorptions * delayed gastric emptying * viral or bacterial infection * physical or mental disability * clinical condition related to impaired digestive system such as cystic fibrosis

Keywords: adolescent carbohydrate counting food insulin index glycemic index type 1 diabetes
remote interrogation in rural emergency departments

Conditions: Heart Disease; Cardiovascular Disease; Heart Failure; Arrhythmias, Cardiac

Summary: a retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the st jude medical merlin@home transmitter. the purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care. up to 10 rural ed sites will enroll a total of 200 patients. one hundred patients will be in the remote monitoring group comprised of patients with sjm devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with sjm devices that are not compatible with the unpaired transmitter or that have a competitor's device.


Eligibility criteria:
inclusion criteria: 1. presents to emergency department with an implanted pacemaker or defibrillator. 2. are 18 years of age or older. 3. are willing and able to provide informed consent for study participation. 4. are willing and able to complete a 30-60 day follow up phone call. exclusion criteria: 1. are unwilling to provide written informed consent.

Keywords: remote monitoring remote care cardiac resynchronization therapy pacemaker implantable cardioverter defibrillator
posterolateral versus lateral internal anal sphincterotomy for chronic anal fissure

Conditions: Anal Fissure

Summary: the present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence.

the present study aimed to compare the standard lateral internal sphincterotomy at 3 o'clock with posterolateral internal sphincterotomy at 5 o'clock in regards healing time, postoperative recurrence and complications, particularly fecal incontinence. we hypothesized that performing internal sphincterotomy in a point midway between the standard lateral position and the posterior midline position would confer better healing and relief of symptoms with less incidence of fecal incontinence while avoiding the development of keyhole deformity.

Eligibility criteria:
inclusion criteria: * adult patients of both genders with chronic posterior anal fissure were included to the study. exclusion criteria: * patients with anterior or lateral anal fissure, * patients with previous anal surgery, * patients with concomitant anorectal pathology, * patients with secondary anal fissure due to crohn's disease or other specific etiology, * patients with any degree of fecal incontinence, * patients with active anorectal sepsis.
confounding factors of chronic endometritis in women with reproductive failure

Conditions: IVF

Summary: the aim of the study is to investigate the confounding factors of chronic endometritis and therapeutic benefits of antibodies targeting plasma cells in women with reproductive failure.

eligible women, based on the inclusion and exclusion criteria, will be recruited from the ivf and/ or miscarriage clinic in the prince of wales hospital/ cuhk medical centre (cumc). endometrial sampling (es) will alternatively be conducted during mid-luteal phase. in natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the luteinizing hormone (lh) surge. the es will be obtained precisely 7 days after lh surge. in artificial cycles, 6mg estradiol will be given daily orally from day 2 of the menstrual cycle for 14+/-1-2 days. transvaginal ultrasound will be performed on day 14 of the estrogen therapy to assess the endometrial thickness and to exclude ovarian activity. if endometrial thickness is ≥8 mm, plasma progesterone level is \< 4nmol/l, progesterone will be commenced using either endometrin (ferring, saint-prex, switzerland) 100 mg tds vaginally. es will be obtained using a pipelle sampler as an outpatient procedure. the es will be obtained precisely 5 days after progesterone supplementation. immunohistochemical staining will be used to determine plasma cells by using a mouse antihuman monoclonal primary anti-cd138 antibody and anti-cd38 antibody. the total number of plasma cell present in the stroma of the entire specimen will be determined and expressed as plasma cell count per unit area of the specimen. if ce is present, antibiotics will be given following the guideline from the hospital authority (ha). then es will be taken again to be re-examined by histology and microbiology.

Eligibility criteria:
inclusion criteria: 1. age 20-45 years; 2. women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation12; or 3. women who failed to conceive after unprotected intercourse for one year; or 4. women who failed failure to achieve a clinical pregnancy after two consecutive cycles of ivf, icsi or frozen embryo replacement cycles where the cumulative number of transferred embryos is no less than four for day-2 embryos and no less than 2 for day-5 embryos (blastocysts), with all embryos being of good quality. exclusion criteria 1. uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural); 2. untreated hydrosalpinx; 3. history of antiphospholipid syndrome; 4. known clinical autoimmune disease; 5. undergoing immunotherapy; 6. abnormal thyroid function; 7. abnormal karyotyping. 8. those with active pelvic inflammatory disease or suspicion of infection etc.

Keywords: chronic endometritis confounding factors reproductive failure infertility ivf infertility women
comparison of weight management programs delivered in large versus small groups

Conditions: Obesity

Summary: the purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. it is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group.


Eligibility criteria:
inclusion criteria: * at least 21 years-old * body mass index (bmi) between 30-45 exclusion criteria: * have lost \>4.5 kg in past six months * have medical condition(s) likely to affect ability to participate in physical activity * planning to relocate from the area in next 12 months * unable or unwilling to attend weekly group sessions * unwilling to accept random assignment

Keywords: obesity weight loss treatment lifestyle
impacts of nitrogen deposition in the natural environment on pollen allergy in belgium

Conditions: Pollen Allergy

Summary: the investigators want to study the effect of environmental nitrogen enrichment on the allergy burden in pollen-sensitized subjects.

the investigators want to study allergen-specific ige reactivity from a cross-sectional sample of pollen-allergic patients (and negative controls) against environmental and experimental pollen samples. following aspects will be compared: * to study the basophil degranulation with different amounts of pollen on fresh patient-derived basophils, to determine the concentration of pollen needed to degranulate 5% (ec5), and 50% (ec50) of basophils. * to study he overall intensity (quantitative), as well as ige-mediated hyper- or hyporecognition of different fragments in the pollen samples (qualitative) in a subset of patients. * to associate allergic rhinoconjunctivitis and food-pollen syndrome related symptoms with reactivity to different pollen samples.

Eligibility criteria:
inclusion criteria: * positive skin prick test for grass and/or birch pollen exclusion criteria: * desensitization therapy during the last two years

Keywords: nitrogen pollution pollen allergy
estrogen exposure and atherosclerosis in postmenopausal women

Conditions: Atherosclerosis; Menopause; Estrogens; Carotid Intima-media Thickness; Coronary Stenoses; Women

Summary: one hundred spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). multivariable analysis confirmed that both age and glucose level directly affected imt. estrogenic exposure, as measured by the allele associated with lower expression of the er beta gene, was protective at the sinus and the wall. findings at the coronary arteries, either moderate or high calcium index (cac) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.

one hundred postmenopausal women living in the urban area of valencia were invited to participate in a cross-sectional study in which a list of clinical and analytical risk factors for cardiovascular disease were assessed. clinical factors included weight, waist circumference, body mass index and blood pressure. analytical parameters included lipidogram, serum glucose and insulin, thyroid hormones (tsh and total t4), vitamin d, ultra-sensitive c-reactive protein, estradiol, and osteoprotegerin. imaging studies were performed to identify the atherosclerotic burden at the carotid artery (intima-media thickness, measured by a high frequency ultrasound probe), and the coronaries (both coronary artery calcium(cac) score and the degree of lumen stenosis). genetic susceptibility was measured by studying single nucleotide polymorphisms of the estrogen receptor. the independent effect of each variable was analyzed with multivariate analysis.

Eligibility criteria:
inclusion criteria: * postmenopausal women free of previous diagnosis of cardiovascular disease, caucasian ethnicity, urban origin, medium or medium-low socioeconomic extraction. exclusion criteria: * previous diagnosis of cardiovascular disease, inability to understand the purpose and conditions of the study..

Keywords: atherosclerosis, endogenous estrogens, age
robotic partial nephrectomy national study

Conditions: Kidney Cancer

Summary: the purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

the primary objective of the study is to describe the characteristics of patients operated for kidney cancer by a robotic partial nephrectomy in france (recruiting centers, patient profile, tumor characteristics). secondary objective(s): 1. to describe the surgical techniques and operative development. 2. to assess the modalities of haemostasis, during robotic partial nephrectomy. 3. to assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications. 4. to assess the outcome of renal function after a robotic partial nephrectomy. this study is a national, multicenter, prospective, cohort.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years old at the time of screening * subject has been diagnosed with renal tumor(s) * subject will undergo a robot assisted partial nephrectomy * subject is willing and able to comply with the requirements of the protocol exclusion criteria: none

Keywords: urology robotic surgery haemostasis partial nephrectomy